Autologous CAR-T Cells Targeting B7-H3 in PDAC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
The purpose of this gene therapy research study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9.CAR.B7-H3 T cells) in patients with pancreatic ductal adenocarcinoma that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration.
Eligibility criteria
Qualifiers
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for releasing personal health information explained to, understood by, and signed by the subject or legally authorized representative.
Age ≥ 18 years at the time of consent.
Eastern Cooperative Oncology Group of 0-1 Performance Status)
Histological or cytological evidence/confirmation of pancreatic ductal adenocarcinoma.
Disqualifiers
Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Subject is not willing and able to comply with study procedures based on the judgment of the investigator.
Trial design
Treatments tested in this trial
- iC9-CAR.B7-H3 T cell infusion
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
Source ClinicalTrials.gov